Why Is the Color of a Medication Important?

According to the US Food and Drug Administration, medication errors are the most common type of mistake made in health care.1 However, the color of a medication can reduce the Read more...

Saving Green With Mitigare® (Colchicine) and the True Blue Savings Card

If you’re one of the more than eight million Americans who live with gout1, you’re probably familiar with the severe pain and discomfort flares can cause. Fortunately for adults with Read more...

Fast Facts on the Mitigare® (Colchicine) True Blue Savings Card

The Mitigare® True Blue Savings Card helps qualified patients save on their colchicine therapy. With the Mitigare® True Blue Savings Card, eligible patients can receive Mitigare® or the authorized generic (colchicine Read more...

3 Things You Should Know About Generic Colchicine 0.6 mg Capsules

Colchicine is a medicine used to help prevent gout flares in adults.1 Gout is a form of inflammatory arthritis that occurs when too much uric acid builds up in the Read more...

Consider Mitigare® (colchicine) 0.6 mg Capsules for Preventing Gout Flares in Adults

Gout is a type of inflammatory arthritis caused by a condition called hyperuricemia.1 Hyperuricemia happens when there is too much uric acid in the body.1 When hyperuricemia becomes severe, uric Read more...

Top Signs You May Want to See a Doctor for Gout

People with gout, a painful form of inflammatory arthritis, sometimes have an initial occurrence, followed by a long period of time when the gout is in remittance before it flares again.  Read more...

Colchicine: How Does It Help Adults with Gout?

Gout is a type of arthritis caused by a build-up of uric acid crystals in the joints and other areas of the body and surrounding tissues. These crystals come from the Read more...

Mitigare® for the Prevention of Gout Flares in Adults: What You Need to Know

Gout is a painful form of inflammatory arthritis1 caused by a condition called hyperuricemia. Hyperuricemia happens when there is too much uric acid in the body. When there is too much uric Read more...

Important Safety Information for Mitigare® (colchicine) 0.6 mg capsules

  • Colchicine 0.6 mg capsules are contraindicated in patients with renal or hepatic impairment who are currently prescribed drugs that inhibit both P-gp and CYP3A4. Combining these dual inhibitors with colchicine in patients with renal or hepatic impairment has resulted in life-threatening or fatal colchicine toxicity. Patients with both renal and hepatic impairment should not be given Mitigare®.
  • Fatal overdoses have been reported with colchicine in adults and children. Keep Mitigare® out of the reach of children.
  • Blood dyscrasias such as myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, and aplastic anemia have been reported with colchicine used in therapeutic doses.
  • Monitor for toxicity and if present consider temporary interruption or discontinuation of colchicine.
  • Drug interaction with dual P-gp and CYP3A4 inhibitors: Co-administration of colchicine with dual P-gp and CYP3A4 inhibitors has resulted in life-threatening interactions and death.
  • Neuromuscular toxicity and rhabdomyolysis may occur with chronic treatment with colchicine in therapeutic doses, especially in combination with other drugs known to cause this effect. Patients with impaired renal function and elderly patients (including those with normal renal and hepatic function) are at increased risk. Consider temporary interruption or discontinuation of Mitigare®.
  • The most commonly reported adverse reactions with colchicine are gastrointestinal symptoms, including diarrhea, nausea, vomiting, and abdominal pain.

Indication

Mitigare® is indicated for prophylaxis of gout flares in adults. The safety and effectiveness of Mitigare for acute treatment of gout flares during prophylaxis has not been studied.

Mitigare® is not an analgesic medication and should not be used to treat pain from other causes.

For Full Prescribing Information please CLICK HERE and for Medication Guide CLICK HERE.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Manufactured by: West-Ward Columbus Inc., Columbus, OH 43228

Important Safety Information for Mitigare® (colchicine) 0.6 mg capsules

  • Colchicine 0.6 mg capsules are contraindicated in patients with renal or hepatic impairment who are currently prescribed drugs that inhibit both P-gp and CYP3A4. Combining these dual inhibitors with colchicine in patients with renal or hepatic impairment has resulted in life-threatening or fatal colchicine toxicity. Patients with both renal and hepatic impairment should not be given Mitigare®.
  • Fatal overdoses have been reported with colchicine in adults and children. Keep Mitigare® out of the reach of children.